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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K261389
Device Name PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
Applicant
Salter Labs
30 Spur Dr.
El Paso,  TX  79906
Applicant Contact Robert Yamashita
Correspondent
Airlife Finland OY
Kuortaneenkatu 2
Helsinki,  FI 00510
Correspondent Contact Tanja-Maria Ranta
Regulation Number868.1720
Classification Product Code
CCL  
Date Received04/28/2026
Decision Date 07/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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